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Departmental Policy
Departmental Procedure
Instructions/Forms
UCVM Diagnostic Services Unit
Document Control Procedure
Classification
Information Management
Approval Authority
Diagnostic Services Unit
Manager
Implementation Authority
Diagnostic Services Unit
Manager
Table of Contents
Purpose
1
Scope
2
Definitions
3
Procedures
4
Responsibilities
5
Instructions/Forms 6
Related Procedures 7
History
10
Effective Date
May 15, 2012
Latest Revision
May 15, 2012
Purpose
1
To describe the process used by the UCVM Diagnostic Services Unit
(DSU) to manage controlled documents. This includes the creation,
revision, approval, storage, distribution, retirement, archiving, and
destruction of controlled documents.
Scope
2
This procedure applies to DSU personnel.
Definitions
3
In this procedure:
a) “Approved Master Document” is an original signed document.
The approval signature indicates approval for issuance and use.
An Approved Master Document may be reproduced for
distribution by the DSU manager or designate.
b) “Change Control” refers to a formal process used to ensure that
changes to a Controlled Document are introduced in a controlled
and coordinated manner.
c) “Controlled Copy” is a photocopy of an Approved Master
Document prepared by the DSU manager or designate for
distribution to appropriate areas. The copy bears a copy number
on the front page and is marked “Do Not Copy.”
d) “Controlled Document” refers to Standard Operating Procedures
(SOP) and forms that have controlled distribution and are subject
to Change Control procedures.
e) “Issuance” is the date that a Controlled Document is finalized and
issued to a department. The document does not become
effective for use until the Effective Date.
DOCUMENT CONTROL PROCEDURE
The electronic version is the official version of these procedures.
DSU SOP #: Q-0001.01
SUPERCEDES DSU #: Q-0001.00
Page 1 of 6
f)
“Effective Date” is the date that a document becomes effective for
use. The time difference between the Issuance and Effective
Dates is to ensure adequate time for personnel training prior to
procedure implementation.
g) “Revision History” is the listing of the documented changes made
to a Controlled Document.
Procedures
4
4.1
General
a)
Photocopying a Master Document by anyone other than the
DSU Manager or designate is prohibited.
b)
Photocopying a Controlled Copy of a Standard Operating
Procedure by anyone other than the DSU Manager or
designate is prohibited.
c)
Controlled forms may be copied by all DSU staff for the purpose
of recording information.
d)
All Controlled Documents are subject to revision control. Only
the current version is to be used and use of any obsolete
document is prohibited.
e)
Controlled Documents may not be provided to persons who are
not employed in the DSU without prior authorization by the DSU
Manager or designate.
4.2
New Documents
a)
An individual initiates a new document as described in SOP Q0004 Change Control Procedure.
b)
The DSU Manager or designate:
4.3
4.4
1)
Assigns a unique number to the document being created
as described in SOP Q-0002 Identification of Controlled
Documents. A new document will have a revision number
of 00.
2)
Records the title and the document number in the
electronic document inventory log.
Revisions to Existing Documents
a)
An individual initiates revision of an existing document or
requests removal of an obsolete document from circulation as
described in the SOP Q-0004 Change Control Procedure.
b)
The DSU Manager or designate:
1)
Provides an electronic copy of the approved document for
editing if requested.
2)
Provides a hard copy for editing if requested. The hard
copy will be clearly marked as an uncontrolled copy.
3)
Attaches the edited copy to the Change Control Record
prior to closing out the Change Control.
Approval of New or Revised Documents
DOCUMENT CONTROL PROCEDURE
The electronic version is the official version of these procedures.
DSU SOP #: Q-0001.01
SUPERCEDES DSU #: Q-0001.00
Page 2 of 6
a)
The DSU Manager or designate:
1)
Performs final formatting and editing as required for
standard DSU or University of Calgary format,
consistency, spelling, grammar, etc.
2)
Creates a hard copy Master Document by printing the
finalized copy.
3) Forwards the Master Document to the author for
signature.
NOTE: University of Calgary-format SOPs have a separate approval
form for the approval signature.
4.5
4)
5)
Signs as the approver.
6)
Saves the finalized electronic document to the appropriate
approved documents folder.
7)
Updates the electronic document inventory log.
Document History File (DHF) and Inventory Update
a)
The DSU manger or designate prepares a Document History
File for each controlled Standard Operating Procedure and form
as follows:
1)
Labels a file folder with the document number, but not the
revision number.
2)
Attaches a Document History Log (FQ-0001A) and
Document Distribution Record (FQ-0001C) to the left side
of the Document History File.
3)
Updates the information on the Document History File
each time a document is processed according to an
approved Change Control.
Attaches the Change Control for that document to the
right side of the Document History File.
4)
5)
6)
4.6
Assigns the effective date to the document once it is
approved.
Inserts the approved new or revised Master Document
into the Document History File without securing it.
Stores the Document History File in a secure location.
Document Distribution
a)
The DSU manger or designate:
1)
2)
Determines the quantity of copies required.
Prepares Controlled Copies for distribution by copying the
Master Document(s).
3)
Labels each page of the controlled copy with “Do Not
Copy.”
4)
Sequentially assigns a copy number on each controlled
copy made.
5)
Prepares and attaches a Procedure Training Record (FQ-
DOCUMENT CONTROL PROCEDURE
The electronic version is the official version of these procedures.
DSU SOP #: Q-0001.01
SUPERCEDES DSU #: Q-0001.00
Page 3 of 6
0001B) to each Standard Operating Procedure (plus
associated forms) being issued.
6)
Records the relevant information as applicable for that
document on the Document Distribution Record already
installed in the Document History File.
7)
Ensures that the controlled copies are transferred to the
relevant area.
NOTE: DSU SOPs using the University of Calgary procedure format
include a line in the footer stating that “The electronic version is the
official version of these procedures.” Because all controlled documents
in circulation within the DSU are copy controlled, the DSU paper copies
of controlled copies will also be considered to be official versions.
4.7
Procedure Training Record (PTR)
a)
Individuals are responsible for completing the PTR issued with
the relevant procedures.
b)
Managers and area supervisors ensure that all personnel who
are required to follow the procedure have read the SOP and
signed the associated PTR prior to performing the procedure.
4.8
Document Retirement, Archival and Destruction
a)
The DSU manager or designate:
1) Logs the return of each document on the appropriate
Document Distribution Record.
2)
3)
Destroys all obsolete Controlled Copies of documents.
Stamps or writes “RETIRED” over the “Effective Date” of
the superseded Approved Master Document in the
Document History File.
4)
Adds the returned Procedure Training Record for each
controlled document to the Document History File for that
document.
5)
Strikes through the remaining space on the Document
History Log, dates and initials the entry.
6)
Stamps or marks the Document History File label on the
folder as “ARCHIVED” if the document is no longer needed
and the entire Document History File is being taken out of
circulation.
Stores the archived Document History Files in a
designated, secure file location.
7)
4.9
8)
Moves the electronic copy of the document to the folder for
retired documents.
9)
Updates the electronic document inventory log.
Periodic Document Review
DOCUMENT CONTROL PROCEDURE
The electronic version is the official version of these procedures.
DSU SOP #: Q-0001.01
SUPERCEDES DSU #: Q-0001.00
Page 4 of 6
a)
b)
c)
Every approved Controlled Document is subject to review by
the owner/authoring department at a minimum of once every
two years.
The DSU manager or designate initiates the review process by
preparing a Document Review Form (FQ-0001D) and
forwarding it to the authoring/owning department.
An individual with appropriate knowledge and experience
reviews the document and determines whether or not it is fit-foruse in its current state. The review includes:
1)
2)
Any controlled forms associated with the document.
Verification that all information including the procedure,
material lists, and referenced documents are current and
relevant.
3)
d)
e)
f)
Recording the assessment in the appropriate sections of
the form.
If no changes are required, the reviewer places a check mark
beside the appropriate box on the Document Review Form,
signs and dates the form and returns it to the DSU manager or
designate.
If the document requires revision, the reviewer initiates a
Change Control Record (FQ-0004B) and returns it with the
signed and dated Document Review Form.
The DSU manager or designate files the completed Document
Review Form in the Document History File
4.10 Storage of Current and Archived Documents
a) Approved current and archived Master Documents are stored in
an appropriate secure location to prevent accidental damage,
loss or unauthorized removal.
Responsibilities
5
5.1
The DSU manager or designate is responsible for:
a) Assigning numbers to new and revised documents.
b) Final formatting and editing of draft documents.
c) Ensuring correct Change Control procedures are followed.
d) Assigning Effective Dates to new and revised documents.
e) Controlling electronic versions of new and revised DSU
documents.
f) Creating a Document History File for each Controlled
Document.
g) Updating the document inventory log.
h) Distribution, retirement, archiving, and destruction of Controlled
Documents.
i) Storage of current and archived Master Documents.
j) Forwarding electronic versions and sign-off sheets for new or
revised documents using the University of Calgary format to the
University of Calgary Access and Privacy Coordinator.
5.2
Managers and supervisors are responsible for:
DOCUMENT CONTROL PROCEDURE
The electronic version is the official version of these procedures.
DSU SOP #: Q-0001.01
SUPERCEDES DSU #: Q-0001.00
Page 5 of 6
a)
5.3
Ensuring that personnel are trained and have read the Standard
Operating Procedure and signed the Procedure Training
Record prior to performing the procedure.
Individuals using controlled documents are responsible for
a)
Verifying that the current version of the document is used.
b)
Determining the need for new procedures, revisions or deletion
of documents in their areas.
Instructions/Forms
6
FQ-0001A Document History Log
FQ-0001B Procedure Training Record
FQ-0001C Document Distribution Record
FQ-0001D Document Review Form
FQ-0004B Change Control Record
Related
Procedures
7
Q-0002 Identification of Controlled Documents
Q-0003 Preparation of Controlled Documents
Q-0004 Change Control Procedure
History
10
Revision #
00
01
Change Control #
CC-10-0001
CC-12-0026
Summary of Change
New document.
Changes to description of how to archive
Document History Files. Minor text edits.
DOCUMENT CONTROL PROCEDURE
The electronic version is the official version of these procedures.
DSU SOP #: Q-0001.01
SUPERCEDES DSU #: Q-0001.00
Page 6 of 6